BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    PreOp v3

    K Number: K252565 · Decision Feb 13, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    183

    Basic Information

    Device Name
    PreOp v3
    K Number
    K252565
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Clouds of Care
    Date Received
    August 14, 2025
    Decision Date
    February 13, 2026
    Product Code
    OLX
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph

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